Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)

NCT ID: NCT05858879

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2026-09-30

Brief Summary

Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.

Detailed Description

This is a randomized quality improvement (QI) project evaluating the impact of notifying patients and their clinicians (primary care, cardiologists, neurologists, or vascular surgeon) of incidental CAC detected on a prior chest CT scan. Patients will be identified by screening previous non-gated chest CT scans and electronic health records. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.

Conditions

ASCVD; Coronary Artery Calcification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Notification with a CAC image

Notification of presence of CAC with a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Group Type: EXPERIMENTAL

Notification of patients and clinicians

Intervention Type: OTHER

Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan (with or without an image) and a recommendation that they discuss this finding and initiation of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification.

Two months after the initial notification, patients and their clinicians who are randomized to notification arms will receive a second message similar to the initial notification.

Notification without a CAC image

Notification of presence of CAC without a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Group Type: EXPERIMENTAL

Notification of patients and clinicians

Intervention Type: OTHER

Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan (with or without an image) and a recommendation that they discuss this finding and initiation of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification.

Two months after the initial notification, patients and their clinicians who are randomized to notification arms will receive a second message similar to the initial notification.

Usual care

The usual care arm will not receive any additional notification beyond the standard of care. If the intervention is successful, we will notify patients in the usual care arm of the presence of CAC and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Notification of patients and clinicians

Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan (with or without an image) and a recommendation that they discuss this finding and initiation of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification.

Two months after the initial notification, patients and their clinicians who are randomized to notification arms will receive a second message similar to the initial notification.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Presence of CAC on non-gated chest CT scans performed from 2021 to 2025

2. Age <85 years

3. Diagnosis of ASCVD(coronary artery disease, peripheral artery disease, or cerebrovascular disease)

4. Visit to Stanford affiliated clinician since 2022 at one of the following Stanford clinics including University affiliated clinics:

1. Internal Medicine

2. Family Medicine

3. Cardiology

4. Neurology

5. Vascular surgery

5. Primary language is English or Spanish

Exclusion Criteria

1. No diagnosis of ASCVD

2. Patients receiving lipid-lowering therapy

3. Dementia

4. Metastatic cancer or active cancer undergoing chemotherapy

5. Hospice

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Fatima Rodriguez

Associate Professor of Medicine (Cardiovascular Medicine)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

70362

Identifier Type: -

Identifier Source: org_study_id